Z-1151-2013Class II

Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic...

Name: Z-1151-2013 Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-02-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-02-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product on 2013-02-21. FDA classified it as Class II and gives the reason as "Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1151-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-21
Posted: 2013-04-18
Terminated: 2014-01-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Product code: KXT Enzyme Immunoassay, Digoxin
Reason for recall: Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall of this product by sending an Urgent Medical Device Recall letter dated February 2013 to all Dimension Vista Drug 4 Calibrator customers who received the affected lots. The letter notified them of the issue, the potential risk to health, and actions to be taken by customers.
Quantity in commerce: 1,638
Distribution: Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product codes and lots: Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1151-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1151-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code KXT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)